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Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population and is associated with a high cardiovascular mortality by coronary artery disease and cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are widely recommended to the control of type 2 diabetes and its complications. This study aims to analyse the effects of different community-based lifestyle programs (exercise or exercise plus dietary intervention) on health and well-being in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Community-based exercise program |
|
| Exercise plus dietary intervention | Experimental | Community-based exercise and dietary intervention program |
|
| Control | No Intervention | Habitual physical activity and habitual dietary pattern |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Community-based exercise program with 3 weekly exercise sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Risk | UKPDS Risk Engine | Baseline, 9 and 21 months |
| Health-Related Quality of Life | SF-36 Health Survey | Baseline, 9 and 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Food Literacy | General Nutrition Knowledge Questionnaire for Adults | Baseline, 9 and 21 months |
| Dietary Pattern | 3-day Food Record | Baseline, 9 and 21 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romeu Mendes, MD PhD | University of Trás-os-Montes e Alto Douro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Trás-os-Montes e Alto Douro | Vila Real | 5000-801 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29477503 | Background | Matos M, Mendes R, Silva AB, Sousa N. Physical activity and exercise on diabetic foot related outcomes: A systematic review. Diabetes Res Clin Pract. 2018 May;139:81-90. doi: 10.1016/j.diabres.2018.02.020. Epub 2018 Feb 23. | |
| 31284568 | Result | Vasconcelos C, Almeida A, Cabral M, Ramos E, Mendes R. The Impact of a Community-Based Food Education Program on Nutrition-Related Knowledge in Middle-Aged and Older Patients with Type 2 Diabetes: Results of a Pilot Randomized Controlled Trial. Int J Environ Res Public Health. 2019 Jul 6;16(13):2403. doi: 10.3390/ijerph16132403. |
| Label | URL |
|---|---|
| Official site | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Dietary intervention | Behavioral | Community-based dietary intervention program |
|
| Physical Fitness | Physical Fitness Test Battery | Baseline, 9 and 21 months |
| Diabetic Foot Risk | International Working Group on the Diabetic Foot Risk Classification) | Baseline, 9 and 21 months |
| Exercise-Related Adverse Events | Number of acute injuries or adverse events during exercise sessions | Baseline, 9 and 21 months |
| Systolic Blood Pressure | mmHg | Baseline, 9 and 21 months |
| Diastolic Blood Pressure | mmHg | Baseline, 9 and 21 months |
| Glycemic Control | Glycated Hemoglobin | Baseline, 9 and 21 months |
| Fast blood glucose | mg/dL | Baseline, 9 and 21 months |
| Total Cholesterol | mg/dL | Baseline, 9 and 21 months |
| Body Fat Mass | Bioelectrical impedance analysis | Baseline, 9 and 21 months |
| Body Lean Mass | Bioelectrical impedance analysis | Baseline, 9 and 21 months |
| Quality of Sleep | Pittsburgh Sleep Quality Index | Baseline, 9 and 21 months |
| Symptoms of Anxiety and Depression | Hospital Anxiety and Depression Scale | Baseline, 9 and 21 months |
| Chronic Pain | Brief Pain Inventory Questionnaire | Baseline, 9 and 21 months |
| Diabetes-Dependent Quality of Life | Audit of Diabetes-Dependent Quality of Life Questionnaire | Baseline, 9 and 21 months |
| Habitual Physical Activity | International Physical Activity Questionnaire | Baseline, 9 and 21 months |
| Waist Circumference | cm | Baseline, 9 and 21 months |
| Falls Risk | Timed Up and Go Test | Baseline, 9 and 21 months |
| Sitting-Time | Hours per day | Baseline, 9 and 21 months |
| Energy Expenditure | kcal/kg/min | Baseline, 9 and 21 months |
| Body Mass Index | kg/m2 | Baseline, 9 and 21 months |
| 31350159 | Result | Vasconcelos C, Almeida A, Sa C, Viana J, Cabral M, Ramos E, Mendes R. Nutrition-related knowledge and its determinants in middle-aged and older patients with type 2 diabetes. Prim Care Diabetes. 2020 Apr;14(2):119-125. doi: 10.1016/j.pcd.2019.06.007. Epub 2019 Jul 24. |
| D004700 | Endocrine System Diseases |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |